Cleared Traditional

K934620 - ORTHOLOC ADVANTIM FIXED STEM NON-POROUS...

K934620 is the FDA 510(k) clearance for ORTHOLOC ADVANTIM FIXED STEM NON-POROUS... by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K934620 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 1994
Decision
339d
Days
Class 2
Risk

K934620 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K934620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date September 01, 1994
Days to Decision 339 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 122d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K934620.
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210 · Dow Corning Wright · Sep 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM
K933290 · Wrightmedicaltechnologyinc · Sep 1994
THICK TIBIAL INSERT
K933289 · Wrightmedicaltechnologyinc · Aug 1994
LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
K933843 · Kirschner Medical Corp. · Aug 1994
FOUNDATION METAL-BACKED PATELLA
K932246 · Encore Orthopedics, Inc. · Jul 1994